F
Sometimes
the QSR causes headache in it?s lack of clarity.
I have a device, a "heat and moisture"-exchanger which in Europe/Canada is class 1 and also in US with the classification code BYD.
It is a device used on a stoma by a spontaniously breathing patient in order to capture the heat and moisture from the exhaled air and return it to the inhaled air. No rocket science there.
However; we now intend to introduce a variant that have an oxygen port. In both Europe and Canada it is now a class II because it is connected to an active medical device.
But what about US?? Can?t find anything.
Anyone who give a hint or can point me to a regulation I can reference for a decision?
Thanks.
I have a device, a "heat and moisture"-exchanger which in Europe/Canada is class 1 and also in US with the classification code BYD.
It is a device used on a stoma by a spontaniously breathing patient in order to capture the heat and moisture from the exhaled air and return it to the inhaled air. No rocket science there.
However; we now intend to introduce a variant that have an oxygen port. In both Europe and Canada it is now a class II because it is connected to an active medical device.
But what about US?? Can?t find anything.
Anyone who give a hint or can point me to a regulation I can reference for a decision?
Thanks.
